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NCT Number: NCT05986604

NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location status: Recruiting

Location contact

Allison Harvey, PhD

CONTACT

[email protected]

510-642-7138

Nena Salazar

CONTACT

[email protected]

‪(925) 421-0083‬

About this study

Life expectancy has increased drastically in the United States. Longer life is too often associated with illness, discomfort, disability, and dependency. Progress toward promoting health and well-being as we age must include the identification of novel treatment targets that are safe, powerful, inexpensive, and deployable. The proposed research will test one such target-patient memory for the contents of treatment.

Over 5 years, we will recruit adults who are 50 years and older and who are experiencing sleep and circadian problems (n = 178, including 20% for attrition). Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight 50-minute, weekly, individual sessions. Assessments will be conducted at baseline, post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).

Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian functioning, (b) improves daytime functioning, (c) improves well-being and (d) improves patient memory by comparing the effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.

Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be associated with better memory for treatment relative to TranS-C alone, and in turn, better memory for treatment will be associated with better sleep and circadian functioning immediately following treatment and at 6FU and 12FU.

Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3. Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older, have fewer years of education, poorer baseline cognitive functioning and more severe baseline sleep disruption and sleep-related impairment.

Exploratory analyses will compare the treatments on (a) patient adherence as well as patient-rated treatment credibility and utilization of treatment elements and (b) provider-rated acceptability, appropriateness, and feasibility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50 years and older;
  • English language fluency;
  • Experiencing a mobility impairment;
  • Low income;
  • Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions.
  • 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
  • Able/willing to give informed consent.

Exclusion criteria

  • Severe untreated sleep disordered breathing (AHI>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale >10);
  • Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
  • Homelessness;
  • Night shift work >2 nights per week in the past 3 months;
  • Substance abuse/dependence only if it makes participation in the study unfeasible;
  • Suicide risk sufficient to preclude treatment on an outpatient basis.

Treatment and study plan

Memory Support Intervention

Behavioral

The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.

Other names: MSI

Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Behavioral

TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.

Other names: TranS-C

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

  2. Sheehan Disability Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment

  3. Satisfaction with Life Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).

  2. Positive and Negative Affect Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect

  3. WHODAS 2.0

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    A measure of functional impairment

  4. Cognitive Failures Questionnaire

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.

  5. Epworth Sleepiness Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.

  6. Memory for Treatment: Cumulative recall

    Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]

    Recall on the Patient Treatment Recall Task

  7. Thoughts and Applications Task

    Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]

    Measures how treatment points have generalized to the participant's thinking and functioning during every day life

  8. Adapted Utilization Scale

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    19-item; 0-4 scale. Scores can range from 0 to 76 (Higher score means more utilization).

  9. Composite Sleep Health Score

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time).

  10. Mean sleep efficiency (Daily Sleep Diary)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100)

  11. Mean total wake time (Daily Sleep Diary)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Daily Sleep Diary mean for total wake time defined as sleep onset latency + wake after sleep onset + Early morning awakening

  12. Mean for total sleep time (Daily Sleep Diary)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

    Daily Sleep Diary mean for total sleep time

  13. Mean for total wake time (Actigraphy)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Actigraphy mean for total wake time defined as sleep onset latency + wake after sleep onset + early morning awakening

  14. Mean for total sleep time (Actigraphy)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Actigraphy mean for total sleep time

  15. Mean for daytime activity (Actigraphy)

    Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

    Actigraphy mean for daytime activity

  16. Provider level: Acceptability of Intervention Measure

    Time frame: Through therapy completion, an average of 8 weeks following baseline

    Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire

  17. Provider level: Appropriateness Intervention Measure

    Time frame: Through therapy completion, an average of 8 weeks following baseline

    Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire

  18. Provider level: Feasibility of Intervention Measure

    Time frame: Through therapy completion, an average of 8 weeks following baseline

    Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire

  19. Provider level: Provider-rated TranS-C Checklist

    Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks

    A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session

  20. Provider level: Memory Support Treatment Provider Checklist

    Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks

    A measure of memory support delivered. This is completed by the therapist at the end of every treatment session

  21. Provider level: Patient adherence via the TARS

    Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks

    A measure of patient treatment adherence completed by the therapist at the end of every treatment session

  22. Provider level: Memory Support Rating Scale, total amount

    Time frame: Randomly selected therapy tapes

    Assesses the total amount of memory support used by a provider via coding of session tapes

  23. Provider level: Memory Support Rating Scale, number of types

    Time frame: Randomly selected therapy tapes

    Assesses the number of types of memory support used by a provider via coding of session tapes

Other outcomes

  1. WatchPAT One

    Time frame: Baseline only

    For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility

  2. Adverse events checklist

    Time frame: Only at post-treatment which is 8-10 weeks after the beginning of treatment

    To assess any adverse events experienced as a result of participating in the study

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline only

    A measure of cognitive functioning/cognitive impairments to determine eligibility

  4. Adapted Credibility Expectancy Questionnaire

    Time frame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment

    Measures the credibility and expectation of improvement from the treatment.

  5. Structured Clinical Interview for Sleep Disorders

    Time frame: Baseline only

    Measures sleep and circadian diagnoses according to DSM-5

  6. Adapted Brief Disability Questionnaire

    Time frame: Baseline only

    A measure of functional impairment

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Harvey, PhD

CONTACT

[email protected]

5106427138

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Official study title

NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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